Description

Pirfenidone Impurity 4 is a specified impurity of the active pharmaceutical ingredient Pirfenidone, an anti-fibrotic medication. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Pirfenidone drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Pirfenidone.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods to detect and quantify this specific impurity.
• Quality Control & Assurance: Employed in routine batch testing of Pirfenidone API to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to identify and track degradation products in Pirfenidone formulations under various stress conditions.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Pirfenidone to minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Pirfenidone Impurity 4
CAS No.	161057-93-8
Molecular Formula	C₁₂H₁₁NO₂
Molecular Weight	201.22 g/mol
Synonyms	5-Methyl-1-phenylpyridin-2(1H)-one; 5-Methyl-1-phenyl-2(1H)-pyridinone; 1-Phenyl-5-methylpyridin-2(1H)-one; Pirfenidone Impurity F; Pirfenidone Related Compound F; Pirfenidone EP Impurity F; Pirfenidone USP Impurity F; PNU-101603 Impurity
EINECS	Contact for details

Quality Control

Every batch of Pirfenidone Impurity 4 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH guidelines. Comprehensive characterization is performed using advanced techniques like NMR, MS, and HPLC. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Handle the material in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.